Neuromuscular Deconditioning and Reconditioning in Colon Cancer Patients: an APA Muscle Rendorcement Program

NCT05099211 | Unknown

• 1 other identifier: COTTET CHU Dijon 2018
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Colon cancer is a real public health problem with more than 46,000 new cases diagnosed per year in France and about 650 cases in Burgundy. Muscle deconditioning (MD), which is characterized by a loss of muscle mass and function, is a frequent consequence in cancer patients and conditions the prognosis. Therefore, it is essential to understand its complex etiology in oncology in order to address the real need for therapeutic countermeasures in clinical practice. DM is a multifactorial process that is exacerbated by therapies. It induces neurogenic and muscular alterations that can profoundly affect patients' quality of life. Currently, analyses of this phenomenon in oncology have been limited essentially to a global evaluation of physical performance, neglecting the muscular and nervous nature of the adaptations responsible for it. Most studies analyzing the therapeutic effects of physical activity (PA) have shown numerous physiological and psychological benefits of aerobic exercise. However, this form of PA is still not very effective in preserving muscle mass. Only muscle strengthening can have an anabolic effect by accelerating the rate of protein synthesis.

Conditions

Colon Cancer; Muscle Strengthening

Outcome Measures

Primary Outcomes (2)

• Acceptability of the program in terms of the number of sessions attended

  Tolerance in terms of level of effort and pain will be tested at each session and will condition the continuation or not of the sessions and therefore acceptability

  Up to Week 30 (evaluation 4) for patients

• Acceptability of the program in terms of the number of sessions attended

  Tolerance in terms of level of effort and pain will be tested at each session and will condition the continuation or not of the sessions and therefore acceptability

  Up to Week 1 (evaluation 1) for healthy patients

Study Arms (3)

Patients muscle strengthening

EXPERIMENTAL

Procedure: Muscle biopsies; Other: Muscle Strengthening; Biological: Blood and urine samples; Other: Evaluation 1 pre-surgery; Other: Evaluation 2 post-surgery; Other: Intermediate Evaluation 3; Other: Final post-training evaluation 4

Aerobic Training Patients

EXPERIMENTAL

Procedure: Muscle biopsies; Biological: Blood and urine samples; Other: Aerobic Training; Other: Evaluation 1 pre-surgery; Other: Evaluation 2 post-surgery; Other: Intermediate Evaluation 3; Other: Final post-training evaluation 4

Healthy patients

ACTIVE COMPARATOR

Biological: Blood and urine samples; Other: Evaluation 1 pre-surgery

Interventions

Muscle biopsies PROCEDURE

Optional In pre-training: Biopsy performed during the digestive surgery procedure Final evaluation (minimum 1 day and maximum 7 days after the last training session): biopsy performed in the digestive surgery department.

Aerobic Training Patients; Patients muscle strengthening

Muscle Strengthening OTHER

3 sessions per week for 18 weeks. Duration: 1 hour Training on different strength training machines for the main muscle groups of the lower and upper limbs. The training load will be gradually increased over the sessions.

Patients muscle strengthening

Blood and urine samples BIOLOGICAL

fasting blood sample taken at assessments 1, 2, 3 and 4 for patients and assessment 1 for controls

Aerobic Training Patients; Healthy patients; Patients muscle strengthening

Aerobic Training OTHER

3 sessions per week for 18 weeks. Duration: 1 hour Training on a "classic" pedal bicycle (called an ergocycle). The intensity and duration of the training will be gradually increased over the sessions and according to the patient's abilities.

Aerobic Training Patients

Evaluation 1 pre-surgery OTHER

Carried out at least 15 days before surgery 1. st visit: * Nutritional assessment * Body composition * Psychometric tests of quality of life + IPAQ Test * VO2pic 2. nd visit: * Neuromuscular tests * Functional tests

Aerobic Training Patients; Healthy patients; Patients muscle strengthening

Evaluation 2 post-surgery OTHER

1. st visit: * Body composition * Nutritional assessment * Psychometric tests of quality of life 2. nd visit: * neuromuscular tests * Functional tests * Familiarization with training equipment if patient participates in re-training

Aerobic Training Patients; Patients muscle strengthening

Intermediate Evaluation 3 OTHER

performed 9 weeks after the beginning of training Identical tests to evaluation 1 + TM6

Aerobic Training Patients; Patients muscle strengthening

Final post-training evaluation 4 OTHER

Tests identical to evaluation 1 + TM6

Aerobic Training Patients; Patients muscle strengthening

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients who are \< 80 years old
• with a first diagnosis of colon cancer, regardless of TNM stage
• to undergo a scheduled excision surgery (laparoscopic colectomy or laparoscopy)
• having given their written consent
• living close to the participating center (\<50 km)
• ability to understand instructions
• Adult who is \< 80 years old
• matched by gender, age and BMI to a patient
• with WHO stage \< 1 at visit V1
• no medical contraindications to the program
• having given written consent

You may not qualify if:

• Protected Adult
• Person not affiliated to national health insurance
• Pregnant or breastfeeding woman
• uncontrolled hypertension
• Suffers from unstable diabetes of any type
• Suffers from heart disease. Pre-surgical VO2 test will confirm authorization.
• Affected by any condition likely to complicate the performance of physical activity (neurological, psychiatric, neuromuscular disorders, severe osteoporosis)
• Patient who received neo-adjuvant chemotherapy
• \- Patient with rectal cancer or other evolving cancer
• Subject has had cancer in the last 5 years
• Subject with a high level of physical activity according to the IPAQ questionnaire
• Person with keloidosis
• Person with bleeding disorders, and/or on anticoagulant and antiaggregant medication
• hypersensitivity to lidocaine
• Patient with a WHO stage \> 1 at the V2 visit

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Anaïs GOUTERON

CONTACT

03 80 29 38 15; anais.gouteron@chu-dijon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: October 29, 2021
• Study Start: July 1, 2022
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: June 21, 2022

Record last verified: 2022-06

Locations

FR (1)